Comparison of the effect of intravenous ketamine and midazolam as a premedication in children undergoing cochlear implantation at the time of separation from parents
Inducing sedation for deaf and muteness children when leaving their parents for cochlear implantation.
Design
This prospective clinical study with parallel groups, double-blinded, will be performed on 74 children who will be referred to Baqiyatallah Hospital for cochlear implantation. Patients will be divided randomly into two groups of 37 patients, midazolam and ketamine.
Settings and conduct
This double-blind study will be conducted on children who will be referred to Baqiyatallah hospital for cochlear implantation. Patients will be randomly divided into midazolam and ketamine groups. The researcher's assistant who will be unaware of the type of used drugs will observe the child in the pre-operative room and fill out the SASS rating form for anxiety scoring. Then, another person will inject the medicine that will be encoded before (blindness will be kept). After calming the child, the researcher's assistant will fill out the form again by removing the child from the parent and inducing anesthesia.
Participants/Inclusion and exclusion criteria
Children aged 6 months to 5 years old in Class 1 and 2 of the American Anesthesiology Association will be included in the study.Children with known sensitivity to ketamine or midazolam, history of using narcotics, age less than 6 months, increased intracranial pressure, history of seizure, upper and lower respiratory tract infection, will be excluded.
Intervention groups
The group of midazolam (receiving 0.1 milligram per kilogram of midazolam produced by Tehran Chemistry Factory diluted with distilled water ) and the ketamine group (1 milligram per kilogram of ketamine produced by Rotex medica diluted with distilled water)
Main outcome variables
The child's sedation when separating from the parents, the child's sedation during induction of anesthesia and child sedation in recovery room.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161022030421N3
Registration date:2019-06-15, 1398/03/25
Registration timing:prospective
Last update:2019-06-15, 1398/03/25
Update count:0
Registration date
2019-06-15, 1398/03/25
Registrant information
Name
Marzieh Lak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 9013
Email address
marziehlak@bmsu.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-01-21, 2018/11/01
Expected recruitment end date
2640-05-22, 2019/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous ketamine and midazolam as a premedication in children undergoing cochlear implantation at the time of separation from parents
Public title
Comparison of the effect of intravenous ketamine and midazolam as a premedication in children .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 6 months to 5 years of age with ASA class I and II, candidate for cochlear implant
Exclusion criteria:
Children with known sensitivity to ketamine or midazolam, as well as history of taking psychiatric medications, age less than 6 months, increased ICP, brain tumor masses, history of seizure, upper and lower respiratory tract infection.
Age
From 6 months old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups of midazolam and ketamine. The person who codes the drug, for example, may will allocate even numbers to ketamine and odd numbers to midazolam, or vice versa.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication will be prepared by a person in the volume of 5 cc and the drug code is written on it. Then another person who will not know the type of medicine will inject the drug into the child and fill out the questionnaire and record the drug code in the questionnaire.The child and parents will not be aware of the type of medicine.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Science, Mollasadra Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.BMSU.REC.1397.031
Health conditions studied
1
Description of health condition studied
Seduction of the chorus and dumb children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sedation when separating from parents
Timepoint
In the pre-operative room, when the child is separated from the parents
Method of measurement
Observe and filling the form of sedation anxiety score scale (SASS)
2
Description
Sedation of the child during induction of anesthesia
Timepoint
On the operating room bed, Induction of anesthesia
Method of measurement
Using the form of sedation anxiety score scale (SASS)
3
Description
Child sedation in recovery
Timepoint
From the child's arrival to the recovery until the release of the recovery
Method of measurement
Using PACU sedation score scale (PACUSSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Midazolam): In this group, midazolam will be given with dose of one tenth of mg / kg of midazolamole in a 5-cc syringe and diluted into 5 cc distilled water. In pre-anesthetic room, the medicine will be injected intravenously, while the baby will be monitored for oxygenation.
Category
Rehabilitation
2
Description
Intervention group (Ketamin): In this group, ketamine with dose of 1 mg per kg will be injected into a 5-cc syringe and diluted into 5 cc distilled water. In pre-anesthetic room, the medicine will be injected intravenously, while the baby will be monitored for oxygenation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Marzieh Lak
Street address
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikh Bahaee Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 2244 9013
Email
marziehlak@bmsu.ac.Ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Hasan Kalantar
Street address
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 3395
Email
k-motamedi@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Marzieh Lak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 212449013
Email
marziehlak@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Marzieh Lak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 212449013
Email
marziehlak@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Marzieh Lak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 212449013
Email
marziehlak@bmsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after unidentifiable people.
When the data will become available and for how long
Starting 1 month after publication
To whom data/document is available
People working in academic institute
Under which criteria data/document could be used
For meta-analysis
From where data/document is obtainable
by Email
What processes are involved for a request to access data/document
By sending a request to the University Vice-Chancellor for Research and obtaining a license